Trial Outcomes & Findings for Syncope Decision Aid for Emergency Care (NCT NCT02971163)

NCT ID: NCT02971163

Last Updated: 2020-05-26

Results Overview

Feasibility of the study will be measured by the number of participants successfully enrolled at the end of the study period.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

Two years

Results posted on

2020-05-26

Participant Flow

After screening 351 patients, 51 randomized, one was excluded because not syncope, resulting in 50 participants enrolled with unexplained syncope from January 2017 to January 2019.

Participant milestones

Participant milestones
Measure
SynDA
The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days. SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.
Control
Patients in the control arm will receive usual emergency care pertaining to syncope.
Overall Study
STARTED
24
26
Overall Study
COMPLETED
20
24
Overall Study
NOT COMPLETED
4
2

Reasons for withdrawal

Reasons for withdrawal
Measure
SynDA
The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days. SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.
Control
Patients in the control arm will receive usual emergency care pertaining to syncope.
Overall Study
Lost to Follow-up
4
2

Baseline Characteristics

Syncope Decision Aid for Emergency Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
SynDA
n=24 Participants
The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days. SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.
Control
n=26 Participants
Patients in the control arm will receive usual emergency care pertaining to syncope.
Total
n=50 Participants
Total of all reporting groups
Age, Continuous
54.5 years
n=99 Participants
60 years
n=107 Participants
58.5 years
n=206 Participants
Sex: Female, Male
Female
12 Participants
n=99 Participants
17 Participants
n=107 Participants
29 Participants
n=206 Participants
Sex: Female, Male
Male
12 Participants
n=99 Participants
9 Participants
n=107 Participants
21 Participants
n=206 Participants
Race/Ethnicity, Customized
Black/African-American
7 Participants
n=99 Participants
11 Participants
n=107 Participants
18 Participants
n=206 Participants
Race/Ethnicity, Customized
Hispanic/Latino
5 Participants
n=99 Participants
5 Participants
n=107 Participants
10 Participants
n=206 Participants
Race/Ethnicity, Customized
White
10 Participants
n=99 Participants
7 Participants
n=107 Participants
17 Participants
n=206 Participants
Race/Ethnicity, Customized
Asian
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Race/Ethnicity, Customized
Other
2 Participants
n=99 Participants
2 Participants
n=107 Participants
4 Participants
n=206 Participants
Control Preferences Scale
1
3 Participants
n=99 Participants
0 Participants
n=107 Participants
3 Participants
n=206 Participants
Control Preferences Scale
2
8 Participants
n=99 Participants
7 Participants
n=107 Participants
15 Participants
n=206 Participants
Control Preferences Scale
3
10 Participants
n=99 Participants
13 Participants
n=107 Participants
23 Participants
n=206 Participants
Control Preferences Scale
4
2 Participants
n=99 Participants
2 Participants
n=107 Participants
4 Participants
n=206 Participants
Control Preferences Scale
5
0 Participants
n=99 Participants
2 Participants
n=107 Participants
2 Participants
n=206 Participants
Control Preferences Scale
Missing data
1 Participants
n=99 Participants
2 Participants
n=107 Participants
3 Participants
n=206 Participants
Subjective Numeracy Score (SNS)
13.2 units on a scale
STANDARD_DEVIATION 2.6 • n=99 Participants
12.6 units on a scale
STANDARD_DEVIATION 2.6 • n=107 Participants
12.9 units on a scale
STANDARD_DEVIATION 2.6 • n=206 Participants
Short Literacy Survey (SLS)
13.2 units on a scale
STANDARD_DEVIATION 2.6 • n=99 Participants
12.6 units on a scale
STANDARD_DEVIATION 2.6 • n=107 Participants
12.9 units on a scale
STANDARD_DEVIATION 2.6 • n=206 Participants
Education
Some High School
1 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
Education
High School Graduate/GED
3 Participants
n=99 Participants
4 Participants
n=107 Participants
7 Participants
n=206 Participants
Education
Some College
8 Participants
n=99 Participants
7 Participants
n=107 Participants
15 Participants
n=206 Participants
Education
College Graduate
4 Participants
n=99 Participants
6 Participants
n=107 Participants
10 Participants
n=206 Participants
Education
Graduate School
8 Participants
n=99 Participants
8 Participants
n=107 Participants
16 Participants
n=206 Participants
Income
Less than $20,000
2 Participants
n=99 Participants
7 Participants
n=107 Participants
9 Participants
n=206 Participants
Income
$20,000 to $29,999
1 Participants
n=99 Participants
4 Participants
n=107 Participants
5 Participants
n=206 Participants
Income
$30,000 to $39,999
2 Participants
n=99 Participants
2 Participants
n=107 Participants
4 Participants
n=206 Participants
Income
$40,000 to $59,999
3 Participants
n=99 Participants
2 Participants
n=107 Participants
5 Participants
n=206 Participants
Income
$60,000 to $79,999
3 Participants
n=99 Participants
0 Participants
n=107 Participants
3 Participants
n=206 Participants
Income
$80,000 to $99,999
2 Participants
n=99 Participants
1 Participants
n=107 Participants
3 Participants
n=206 Participants
Income
$100,000 or more
4 Participants
n=99 Participants
5 Participants
n=107 Participants
9 Participants
n=206 Participants
Income
Rather Not Say
7 Participants
n=99 Participants
5 Participants
n=107 Participants
12 Participants
n=206 Participants
Canadian Syncope Risk Score
Low: 0 (≈2% risk)
3 Participants
n=99 Participants
6 Participants
n=107 Participants
9 Participants
n=206 Participants
Canadian Syncope Risk Score
Medium: 1 (≈3% risk)
13 Participants
n=99 Participants
15 Participants
n=107 Participants
28 Participants
n=206 Participants
Canadian Syncope Risk Score
Medium: 2 (≈5% risk)
8 Participants
n=99 Participants
5 Participants
n=107 Participants
13 Participants
n=206 Participants

PRIMARY outcome

Timeframe: Two years

Feasibility of the study will be measured by the number of participants successfully enrolled at the end of the study period.

Outcome measures

Outcome measures
Measure
SynDA
n=24 Participants
The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days. SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.
Control
n=26 Participants
Patients in the control arm will receive usual emergency care pertaining to syncope.
Number of Participants at End of Study
20 Participants
24 Participants

SECONDARY outcome

Timeframe: Within 2 hours post ED disposition on Day 1

One brief post-encounter survey will be given to the patient to assess their knowledge surrounding syncope and their satisfaction with their care during the ED visit. Scores full range is 0-9, higher score indicates more knowledge

Outcome measures

Outcome measures
Measure
SynDA
n=24 Participants
The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days. SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.
Control
n=26 Participants
Patients in the control arm will receive usual emergency care pertaining to syncope.
Patient Knowledge
5.2 score on a scale
Standard Deviation 1.8
5.3 score on a scale
Standard Deviation 1.8

SECONDARY outcome

Timeframe: Within 2 hours post ED disposition on Day 1

Decisional quality will be measured by administering the Decisional Conflict Scale to all patients after disposition decision has been made. The decisional conflict scale total score range from 0 (no decisional conflict) to 10 (extremely high decisional conflict).

Outcome measures

Outcome measures
Measure
SynDA
n=24 Participants
The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days. SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.
Control
n=26 Participants
Patients in the control arm will receive usual emergency care pertaining to syncope.
Decisional Conflict Scale
8.9 score on a scale
Standard Deviation 1.5
9 score on a scale
Standard Deviation 1.6

SECONDARY outcome

Timeframe: Day 1 and 30 day follow up period

Number of patients admitted to the hospital or sent to observation unit at index visit and number of patients admitted to the hospital, or had an office visit or during 30-day follow-up period

Outcome measures

Outcome measures
Measure
SynDA
n=24 Participants
The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days. SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.
Control
n=26 Participants
Patients in the control arm will receive usual emergency care pertaining to syncope.
Utilization Outcomes
Admitted to hospital Day 1
0 Participants
0 Participants
Utilization Outcomes
Sent to observation unit Day 1
4 Participants
7 Participants
Utilization Outcomes
Admitted to hospital 30 day follow up period
1 Participants
1 Participants
Utilization Outcomes
Office visit 30 day follow up period
14 Participants
17 Participants

SECONDARY outcome

Timeframe: 30-day follow-up period

Number of participants with repeat visits to the ED during 30-day follow-up period

Outcome measures

Outcome measures
Measure
SynDA
n=20 Participants
The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days. SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.
Control
n=24 Participants
Patients in the control arm will receive usual emergency care pertaining to syncope.
Number of Participants With Repeat Visits to the ED
1 Participants
2 Participants

SECONDARY outcome

Timeframe: at 30 days

Number of participants with clinical diagnosis at 30 days after index visit to the ED

Outcome measures

Outcome measures
Measure
SynDA
n=20 Participants
The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days. SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.
Control
n=24 Participants
Patients in the control arm will receive usual emergency care pertaining to syncope.
Participants With New Significant Clinical Diagnosis
Acute Stroke
1 Participants
0 Participants
Participants With New Significant Clinical Diagnosis
Heart Failure
1 Participants
0 Participants
Participants With New Significant Clinical Diagnosis
Cardiac Arrhythmia
0 Participants
1 Participants
Participants With New Significant Clinical Diagnosis
Large Pericardial Effusion
0 Participants
1 Participants

SECONDARY outcome

Timeframe: Day 1

Number of diagnostic test (which may include but not limited to exercise stress testing, echocardiography, computed tomography scans) performed

Outcome measures

Outcome measures
Measure
SynDA
n=24 Participants
The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days. SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.
Control
n=26 Participants
Patients in the control arm will receive usual emergency care pertaining to syncope.
Number of Diagnostic Testing
1 Participants
1 Participants

SECONDARY outcome

Timeframe: up to 2 years

The degree of patient involvement in the disposition decision as measured by the OPTION (observing patient involvement in decision making) scale. The OPTION-5 scale is a brief, 5-item instrument used by a trained observer to measure the degree of patient involvement in clinical decision-making and has demonstrated validity and reliability. Full scores range from 0 to 100, with higher scores indicating higher levels of patient involvement.

Outcome measures

Outcome measures
Measure
SynDA
n=24 Participants
The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days. SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.
Control
n=26 Participants
Patients in the control arm will receive usual emergency care pertaining to syncope.
OPTION-5 Scale
52.0 score on a scale
Standard Deviation 18
26.6 score on a scale
Standard Deviation 21

Adverse Events

SynDA

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Marc A. Probst

Mount Sinai Medical Center

Phone: 212-824-8094

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place